Extraction form for project: Screening for Glaucoma in Adults - 1 of 2

Design Details

1. Study design

Arms

Arm NameArm Description
A. Dorzolamide 2% three times daily (n=536)
B. Placebo (n=541)

Sample Characteristics

1. N
A. Dorzolamide 2% three times daily (n=536)
B. Placebo (n=541)
Total
2. Baseline population
A. Dorzolamide 2% three times daily (n=536)
B. Placebo (n=541)
Total

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalVision disorderIOP, mean reduction from baseline to 5 years
  • All Participants
  • 5 years
CategoricalVision disorderVisual field defect or optic disc change
  • All Participants
  • end of study
ContinuousHarm/adverse eventSerious adverse events
  • All Participants
  • end of study
ContinuousHarm/adverse eventOcular adverse events related to study drug
  • All Participants
  • end of study

Risk of Bias Assessment

1. Random assignment
2. Allocation concealed
3. Groups similar at baseline
4. Eligibility criteria specified
5. Blinding: outcome assessors or data analysts
6. Intention-to-treat analysis
7. Reporting of attrition, contamination, etc.
8. Differential loss to followup or overall high loss to followup
9. Appropriate analysis including cluster correlation
10. Funding source
11. Randomization adequate?
12. Allocation concealment adequate?
13. Groups similar at baseline?
14. Eligibility criteria specified?
15. Outcome assessors masked?
16. Care provider masked?
17. Patient masked?
18. Attrition and withdrawals reported?
19. Loss to followup differential/ high?
20. People analyzed in the groups in which they were randomized?
21. Quality

Results

Categorical


Vision disorder (IOP, mean reduction from baseline to 5 years)

All Participants
Descriptive StatisticsBetween Arm Comparisons
A. Dorzolamide 2% three times daily (n=536)B. Placebo (n=541)
vs.
5 years
Percentage
p value
Within Arm ComparisonsNet Comparisons
A. Dorzolamide 2% three times daily (n=536)B. Placebo (n=541)
vs.

Vision disorder (Visual field defect or optic disc change)

All Participants
Descriptive StatisticsBetween Arm Comparisons
A. Dorzolamide 2% three times daily (n=536)B. Placebo (n=541)
end of study
Percentage
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
A. Dorzolamide 2% three times daily (n=536)B. Placebo (n=541)

Continuous


Harm/adverse event (Serious adverse events)

All Participants
Descriptive StatisticsBetween Arm Comparisons
A. Dorzolamide 2% three times daily (n=536)B. Placebo (n=541)
end of study
Percent
Mean Difference (MD)
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
A. Dorzolamide 2% three times daily (n=536)B. Placebo (n=541)

Harm/adverse event (Ocular adverse events related to study drug)

All Participants
Descriptive StatisticsBetween Arm Comparisons
A. Dorzolamide 2% three times daily (n=536)B. Placebo (n=541)
end of study
Percent
Mean Difference (MD)
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
A. Dorzolamide 2% three times daily (n=536)B. Placebo (n=541)